510(k) K241766
- Device
- QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
- Applicant
- Fysicon BV
- 510(k) number
- K241766
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-27
- Date received
- 2024-06-20
- Regulation
- 870.2300
- Classification name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Cornelis (Eric) Van Antwerpen
- Address
- Hoogheuvelstraat 114 Oss NL 5349 BA 5349 BA
FDA Registration Numbers
- 2221819
- 9710602
- 3004009431
- 3007615597
- 3031563234
- 3003174284
- 2027454
- 1054713
- 3004145393
- 8040537
- 3008977358
- 3006733253
- 3009156722
- 3010041430
- 3016701404
- 1066427
- 3013188547
- 3009077524
- 3004091281
- 3007137598
- 3009001657
- 3006648320
- 1051786
- 3011683100
- 1833920
- 3030447506
- 3010390468
- 3013557562
- 3008716327
- 3010399798
- 3003294644
- 3010032903
- 8030229
- 3008164770
- 3007481893
- 8020045
- 3013298431
- 3015142815
- 3012238587
- 3009673645
- 3005569927
- 3005803793
- 3006808382
- 3010392999
- 9615102
- 1221108
- 2080783
- 3036798186
- 3010157426
- 3010863450
- 3014856521
- 3015529350
- 8021084
- 1066270
- 3035111606
- 3010097171
- 3018514222
- 8040564
- 3009503584
- 3008729547
- 3012421607
- 3037341611
- 3007413079
- 1058584
- 3016618143
- 3006546174
- 3014886121
- 3027256461
- 3007603826
- 8043459
- 8010482
- 3003768277
- 3004906872
- 3010120135
- 3012528160
- 3003832357
- 2936999
- 3000976525
- 3014579161
Source Documents
Other 510(k) Records For Product Code MWI
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|---|---|---|---|
| K253436 | c-med0 alpha | Cosinuss GmbH | 2026-04-30 |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025-06-06 |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025-02-14 |
| K243146 | iCare APP | Ihealth Labs, Inc. | 2025-02-03 |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024-12-20 |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | 2024-12-10 |
| K233446 | AMC Health CareConsole | Amc Health | 2024-09-27 |
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024-09-24 |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024-06-26 |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | 2024-06-25 |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024-04-01 |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2024-03-08 |